STARLED1 EVO Users Manual Versions R-F Rev 2012-01 Jan 2012

LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

USER’S MANUAL - ENGLISH

Valid for the following versions : STARLED1 EVO R – F STARLED1 EVO R – F STARLED1 EVO R – F STARLED1 EVO R – F STARLED1 EVO R

/105 (trolley mounted) /102 (wall mounted) /103 (table mounted) /101 (rail mounted) /108 (ceiling mounted)

This document belongs to ACEM S.p.A. and cannot be copied or distributed without authorization.

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LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

INDEX 1. GENERAL INFORMATION 1.1 INTRODUCTION 1.2 FEATURES 1.3 MANUFACTURER INFORMATION 1.4 CAUTION!! 1.5 INSPECTION UPON RECEIPT AND COMPLAINTS 1.6 ENVIRONMENTAL CONDITIONS

2. PARTS 2.1 LIGHT 2.2 TROLLEY 2.3 CEILING MOUNT 2.4 WALL BRACKET OR TABLE CLAMP 2.5 TABLE CLAMP 2.6 RAIL CLAMP

3. START-UP 3.1 USE PURPOSE AND CLASSIFICATION 3.2 SAFETY ADVICE 3.3 VISUAL INSPECTION AND FUNCTIONING TEST BEFORE USE 3.4 INSTALLATION AND START-UP 3.5 TROLLEY ASSEMBLY 3.6 CEILING POLE ASSEMBLY 3.7 WALL BRACKET ASSEMBLY 3.8 TABLE CLAMP ASSEMBLY 3.9 RAIL CLAMP ASSEMBLY 3.10 LIGHT HEAD ASSEMBLY

4. USE 4.1 SWITCHING ON/SWITCHING OFF 4.2 BRIGHTNESS ADJUSTMENT 4.3 POSITIONING AND ORIENTATION 4.4 TROLLEY USE

5. MAINTENANCE 5.1 CLEANING, DISINFECTION AND STERILIZATION 5.2 STAYING POWER ADJUSTMENT OF THE ARM (ONLY FOR R VERSION) 5.3 LIGHT HEAD REPLACEMENT 5.4 MOVING

6. TECHNICAL FORM 6.1 ELECTRICAL FEATURES 6.2 LIGHT SOURCE TECHNICAL FEATURES 6.3 DIMENSIONS AND WEIGHT 6.4 FURTHER DATA

5 5 5 5 6 6 6

7 7 7 8 8 8 8

9 9 9 9 10 10 11 12 12 13 13

14 14 14 14 14

15 15 15 16 16

17 17 17 17 17

7. DISPOSAL

18

8. COMPLAINTS

18

9. DECLARATION OF CONFORMITY

19

10. WARRANTY

20

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LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

1. GENERAL INFORMATION 1.1 Introduction STARLED1 EVO is a single light lamp using LED as new conception and high power light source. The light head is mounted on a adjustable arm – either articulated or flexible - and can be rotated, oriented and tilted in every direction. The articulated version (ceiling version excluded) is available with internal or external power supply unit (embedded in the plug).

1.2 Features This new technology enables to obtain a unparalleled quality of light. with a colour temperature of 4900°K. Among other advantages, a colour temperature of 4900°K, and the sole feature, peculiar of this technology, of emitting light without UV rays (ultraviolet, detrimental for one’s health) and IR (infrared rays) responsible for the light flux heat, and of the dehydration of the skin. The easy grip and the adjustable light head allow a quick and accurate positioning in every condition. Compact dimensions and ease of handling are other important features of STARLED1 EVO. The electronics functioning studied on purpose gives the maximum efficiency of the device and an intuitive and simple use of controls.

1.3 Manufacturer information The manufacturer of the product is:

ACEM S.p.A. Via della tecnica, 29 40050 Argelato, Bologna – ITALY E-mail Ph Fax

: [email protected] : +39.051.721844 : +39.051.721855

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USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F 1.4 Caution!!

These instructions go together with the unit and must always be kept near the lamp for future reference. Read carefully these instructions before use for a proper and correct utilization of the lamp according to their destination both for patient and operator safety.

1.5 Inspection upon receipt and complaints It is suggested to inspect the product and/or accessories upon their receipt to check possible flaws or damages due to shipment. See chapter: “Visual inspection and functioning test before use” Complaints can be accepted only if immediately communicated to the forwarding agent or representative. See chapter: “Complaints”

1.6 Environmental conditions FUNCTIONING TEMPERATURE RELATIVE HUMIDITY AIR PRESSURE

MIN. +10 °C 30% 700 hPa

MAX. +40 °C 75% 1060 hPa

MIN. -10 °C 20% 700 hPa

MAX. +50 °C 90% 1060 hPa

TRANSPORT/STORAGE TEMPERATURE RELATIVE HUMIDITY AIR PRESSURE

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LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

2. PARTS 2.1 Light R Version

F Version

2.2 Trolley

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

2.3 Ceiling mount

2.4 Wall bracket or table clamp

2.5 Table clamp

2.6 Rail clamp

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

3. START-UP 3.1 Use purpose and classification STARLED1 EVO is a lamp for medical purpose used for patient lighting. Its light emission features accurately identifies all particulars avoiding colour change or temperature increase on the light field. According to the particular technical standard EN 60601-2-41:2009-12 LUMINAIRE FOR DIAGNOSIS luminaire to illuminate the body of the PATIENT locally in order to support diagnosis or treatment which could be interrupted without any hazard for the PATIENT in case of failure of the light. NOTE It is not intended to be used in operating rooms. REF.: EN 60601-2-41:2009-12 Par. 2.103 According to the general technical standard (EN 60601-1:2006-10 section 6) and particular technical standard (EN 60601-2-41:2009-12, § 201.3, § 201.6) Based on the kind of protection against electrical dangers: Class I device. Based on the kind of protection against solid foreign objects and water penetration: IP31. Based on the kind of use safety in the presence of combustible mixtures of anaesthetics with air, oxygen or nitrogen protoxide: device not suitable in the presence of the above mentioned substances. Based on the use conditions: device for continuous use. According to 93/42/CEE Directive – annex IX Short term medical device, active and non invasive destined to the local illumination of the patient. The device belongs to Class I according to the rule1.

3.2 Safety advice The lamp is not suitable to be used in explosion risk areas. Use the lamp in proper premises only, built and equipped in conformity with the directions in force in point of safety (IEC 60364-7-710). Do not look frontally inside the lamp when it is turned on and do not insert reflecting objects during its operation. Do not turn the light beam directly or indirectly into third parties’ eyes. Due to the high lighting power there is the potential danger of dazzle and visual system damage. For an efficient lighting, the distance between the light emission surface of the lamp and that of patient should not be inferior to 30 cm. Do not place or hang objects on the head or arm of the lamp to avoid that they fall down on the operating area and cause the lamp an unstable position. This could also damage the mechanical parts of the lamp. The light head (specially its superior part) must not be covered during operation; as a matter of fact this would block the thermal exchange with the environment and the lamp could get overheated. Avoid bumps of mobile arms and light head. A strong bump can damage the lamp and paint pieces can split and fall on the operating field.

3.3 Visual inspection and functioning test before use A visual control must be carried out after installation: Mobile mechanical parts check Check the mechanical functioning of the lamp through orientation and rotation movements of the mobile mechanical parts. Reflector check Visually check that both external plastic components and light components inside are not damaged. In case of damage the lamp MUST NOT be switched on and MUST NOT be used until repaired. All LEDs of the light head must be enlightened when the lamp is turned on. Visually check that no damage occur to the light head and controls, i.e. dents or scratches that could prejudice a correct functioning of the device.

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LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

3.4 Installation and start-up All ACEM lamps are provided with parts and components for installation and connection. STARLED1 EVO assembly and installation must be carried out according to assembly instructions and only by ACEM collaborators or by assembly companies authorized by ACEM itself. A non state-of-the-art assembly could cause the lamp to come off from its support falling down and wounding patient and personnel during its functioning. The electrical installation must comply with IEC 60364-7-710 directives requiring a protection by fuses as well as a switch for the simultaneous interruption on every pole of the lamp power supply. For more detailed information please refer to assembly instructions. The lamp is provided with plug or terminal block for mains connection on the flange in the ceiling mounted configuration. The owner can start the lamp only if the manufacturer or supplier: a) has checked it with a functioning test on its area of use. b) has trained the person in charge of its functioning according to use instructions.

3.5 Trolley assembly The trolley is composed of 3 parts: The 5-arm base and castor wheels B and the central plastic cover A. The vertical pole (fixed section and extensible section) C. Fixing kit D. The 5 arms of the base are in-factory checked. However, to be sure that the wheels are perfectly on level and flat when you receive it, you should do the following: Put the base on a perfectly smooth and flat surface. If the base is not on level, you can act on the arms, one at a time. For example, if an arm is "lifted" from the floor, slightly loosen the bolt near the centre of the base and then press on the arm to align it with the other; then tighten back the bolt.

C

A

B D

Assemble the trolley following these instructions: Insert the cover A into the centre of the base B by pushing its end. Unscrew the bolt D from the pole and insert it into the hole in the centre of the base, from the bottom upwards. Insert pole C into the centre of the base B and tighten it through the screw D up to the complete manual clamping. Tighten the bolt with the help of a 17 mm wrench. The assembly is finished and the lamp can be installed. See par. 3.10

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LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

3.6 Ceiling pole assembly Before installation, find the position where the lamp will be anchored keeping into consideration the operational needs, the overall dimensions of the lamp and the static and dynamic loading capacity features of the ceiling. Make the holes on the ceiling according to the following template.

Make 4 fixing holes in the ceiling according to the specifications for the ceiling type used for the installation given by the dowels manufacturer. The holes diameter on the flange is 8 mm (see above). Insert the fixing elements in the ceiling and assemble the flanged pole. If necessary use the washers to balance the pole itself. Check the ceiling fixing to estimate the loading capacity. Make the electric connection on the terminal block according to the specifications of the label on the flange. Position the ceiling cover (A) and the block ring (B) (see following pic.). Tighten the screw on the ring with a 2,5 Allen key. Assembly of ceiling pole is finished.

Install the lamp as follows:

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

Ceiling cover (A)

Stop ring (B)

Is now possible to go on with the installation of the lamp, in the following way:

Remove the safety ring – seeger - from the tube of the ceiling pole.

Insert the lamp in the tube and let the cable pass through the hole. Assemble the seeger being sure that it is perfectly in its position. Connect the power supply plug. The lamp assembly is finished.

3.7 Wall bracket assembly Find the wall bracket. (See par. 2.4 too). Find the position on the wall where the lamp will be installed taking into consideration operative requirements, dimensions of the lamp, dynamic and static features of the wall. For this reason it is suggested not to install the lamp on plasterboard walls. The orientation of the wall bracket must respect exactly that of the picture at par. 2.4. Mark on the wall the 3 fixing holes by using the same bracket as template. Use 3 dowels for wall - Ø6 (not provided) for fixing. Operate on the wall according to the procedures of a duly carried out work. Fasten the bracket to the wall with 3 special screws. The assembly is finished and the lamp can be installed. See par. 3.10

3.8 Table clamp assembly The table clamp is the same one used for the wall bracket assembly. This document belongs to ACEM S.p.A. and cannot be copied or distributed without authorization.

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LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

The assembly procedure and the considerations regarding position and resistance are valid for the wall version as well. It is possible to install the clamp both on a lateral side of the table (in this case see picture at par. 2.4 for correct orientation) as on the top of the table (in this case there are no particular instructions about orientation). Obviously, no dowels for wall will be used but 3 screws (not provided) according to the material used for the installation. The installer experience will determine the fixing type. For this reason, ACEM is not responsible for the installation quality. Assembly is finished and the lamp can be installed. See par. 3.10

3.9 Rail clamp assembly Under construction.

3.10 Light head assembly The lamp is provided with arm and clutch and is supplied ready for use. To finish the installation procedure after one or more phases described in the previous paragraphs, it is enough to insert the arm in its bushing. To do this it is necessary to unscrew of some millimetres the safety screw on the side of the bushing releasing the clutch completely and insert the arm pin into the bushing hole up to the end. During this operation, be careful and keep the pin in a vertical position and lined up with the hole not to avoid damages to the pin itself (deformity or taking an oval shape). Screw the safety screw up to the end. In this way the arm can rotate (as far as possible) but it cannot be removed from the bushing accidentally. Assembly of lamp is finished.

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USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

LUMINAIRE FOR DIAGNOSIS

STARLED1 EVO R - F 4. USE 4.1 Switching on/switching off

STARLED1 EVO switching on and off is possible thanks to the switch placed on the posterior part (over the pivot point of the supporting arm of the light head). Position I Position 0

ON OFF

4.2 Brightness adjustment STARLED1 EVO brightness adjustment is possible thanks to the Touching control panel placed on the frontal part of the light head recognizable for its soft blue colour. It is possible to adjust the light intensity for the whole range from 0% (bottom) up to 100% (top) moving your finger vertically on the control panel or directly touching in the position of the desired light intensity. The set up in use is confirmed by the green LEDs placed along the area itself.

4.3 Positioning and orientation STARLED1 EVO can be easily adjusted and oriented by rotating the light head around the arm pivot point axe and acting on the flexible arm bringing it in the desired position. The lamp will remain in this position except for a first light bedding of the spring system. The arm can be grasped in every point along its extension. It is important to make all movements acting on the arm (picture 4.3-1) and on the light head with light rotation movements around the arm pivot point axe only (picture 4.3-2). It is possible to adjust the”hardness” of the clutch (the ability to keep the light head firm) and thus the adjustment and orientation ease of the light head.

Picture 4.3-1 Picture 4.3-2

4.4 Trolley use During the standard use, the extractable part of the vertical pole (“C” – par. 3.5) must not be extracted for more than 50 cm. Besides, when moving the lamp from an area to another one or when you are not sure of the obstacles on the way, keep the vertical pole at the minimum height before starting any movement.

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

5. MAINTENANCE 5.1 Cleaning, disinfection and sterilization Always disconnect the unit from the mains during cleaning and maintenance of the lamp. The surface can be easily cleaned by wiping with a damp cloth and using conventional cleaning agents. Use only disinfectants containing less then 20% of alcohol. Do not pour liquids on the light head.

5.2 Staying power adjustment of the arm (only for R version) The support arm has two clutches useful to adjust the effort during the orientation and positioning staying power of the light head. CAUTION! Clutches are already set and they do not normally need further adjustments. Described operations have to be carried out only if the arm presents some difficulties in maintaining the desired position as time passes. Adjustments have to be carried out using the supplied key. To adjust the staying power of the first part of the arm (BI) act on the clutch through hole ‘A’. To adjust the staying power of the second part of the arm (BI) act on the clutch through hole ‘B’. The counter clock-wise adjustment on the point ‘A’ and ’B’ increases the clutch power: make a stronger effort to move the arm. On the contrary, a clock-wise adjustment decreases clutch power: the arm moves more freely.

B2

B B1

A

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

5.3 Light head replacement Attention: all the operations below must be carried out after having previously disconnected the unit from the mains socket. NOTE:

light head replacement can be carried out only upon ACEM authorization exclusively by specialized personnel.

For light head replacement it is necessary to contact ACEM directly to receive further information about.

5.4 Moving If the lamp needs to be moved follow the below mentioned instructions: CAUTION! The lamp contains delicate components sensitive to strong mechanical stresses. Thus, if some parts or the whole lamp need to be moved, it is suggested to ask for ACEM permission before operating. The non-compliance with the above mentioned procedure causes an immediate warranty period termination. Always observe the following instructions: Light head packing This is the most delicate part of the device and for this reason it must be absolutely properly handled and protected both during disassembly and transport, by operating as follows: Put the head of the lamp and the arm in an envelope of bubble wrap and close it with adhesive tape with the wording “fragile”. The arm has a special flexibility degree but do not twist or bend the sections with spring system excessively during packing operations not to prejudice its future correct functioning. Prepare a carton box (suitable for lamps), and fill it with 10 cm. of polystyrene into pieces. Place inside it:

the light head and its arm the documentation (user’s manual, report, etc.)

Fill the remaining empty part of the box with polystyrene into pieces and close it with adhesive tape with the wording “fragile”. Trolley packing The trolley is composed by 4 parts: the base, the plastic cover, the painted pole section and the chromium-plated pole section. Pack the 4 parts separately with bubble wrap and fasten it to the column with adhesive tape. Use a carton box of suitable dimensions and put the parts inside it carefully. Fill the remaining empty parts of the box with bubble wrap sheets, polystyrene into pieces or something else to protect them from bumps during transport. Put the forwarding stick-on label in the centre of the box and fill in it correctly.

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

6. TECHNICAL FORM 6.1 Electrical features Power Supply (with supplied PSU) Low DC voltage version Power Consumption Product Class EN60601-2-41

100-240VAC ±10% - 50/60 Hz 12VDC 12W I

6.2 Light source technical features Light source Average life Max power Max light flux Light adjustment Colour temperature Colour Rendering Index Light field dimension @ 50 cm, D50

Hi Power LEDs 50.000 hours 12 W 60.000 lux @ 50 cm 0 % – 100 % 4.900 °K 95 9 cm

6.3 Dimensions and weight LAMP Rotation around the fixing axis Vertical rotation of light head Horizontal rotation of light head

330° 180° 330°

Light head diameter Weight

12 cm 0,8 Kg

Total arm length (R) Total arm extension (R) Total arm length (F) Total arm extension (F)

104 cm 102 cm 84,5 cm 80 cm

TROLLEY Min – max height from the floor (trolley only) Trolley base diameter Weight

80-130 cm 68 cm 3 Kg

CEILING POLE Rotation around the fixing axe Pole length (steady section) Adjustable section length range Pole total length range

330° 60 cm 50 cm 60-110 cm

6.4 Further data Light Head external temperature IP degree

40 °C max IP31

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

7. DISPOSAL At the end of its lifetime, the equipment must be disposed according to directives and procedures foreseen by the Law. Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS). According to the a.m., notice is given that: It is forbidden to dispose WEEE as unsorted municipal waste. Collect such WEEE separately; When supplying a new product, distributors shall be responsible for ensuring that such waste can be returned at least free of charge on a one-toone basis as long as the equipment is of equivalent type and has fulfilled the same functions as the supplied equipment. In other cases, the customer is bound to return the equipment to a reuse centres, treatment and recycling facilities. The equipment and its components, comply with the RoHS directive on restriction of use of hazardous substances. There are not potential effects on the environment and human health as a result of the presence of hazardous substances in the equipment The symbol:

Also reported on equipment label, means that it must be disposed separately. Penalties are applicable in case the equipment is disposed improperly or abusively to what’s foreseen by the Law.

8. COMPLAINTS Complaints for possible damage during transport will be accepted only if communicated immediately to the seller or the forwarding agent. In case of return of the product use, if possible, the original packing of the lamp and always specify the following data: - Name and address of the customer - Serial number of the article - Fault description

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STARLED1 EVO R - F

USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

9. DECLARATION OF CONFORMITY

declaration of conformity

Manufacturer name Manufacturer address Product type Product name Product class (MDD 93/42/EEC)

: ACEM S.p.A. : Via della tecnica, 29 - 40050 Argelato, Bologna – ITALY : Luminaire for diagnosis : STARLED1 EVO :I

The product complies with the requirements of the Medical Devices Directive 93/42/EEC, and with those of harmonized standards EN 60601-1:2006 “Medical electrical equipment. Part 1: General requirements for basic safety and essential performance”. EN 60601-2-41:2009 “Medical electrical equipment. Part 2: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis”.

Stamp and Gen. Manager Signature

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USER’S MANUAL Rev. 2012-01 Date: 06/02/2012

10. WARRANTY ACEM S.p.A. Via della tecnica, 29 40050 Argelato, Bologna – ITALIA Tel.: +39.051.721844 (r.a.) – Fax: +39.051.721855

Validity 24 (twenty-four) months

ARTICLE : Luminaire for diagnosis MODEL : STARLED1 EVO

The warranty is valid for a period of 24 (twenty-four) months starting from the date of the purchase receipt and cannot be extended for the inactivity of the device due to repair. Thus the customer will have to communicate the working deficiency of the product to our seat within the aforesaid expiration or he/she will loose the right to make use of the warranty. Technical service under warranty is carried out by authorised technicians only. When the customer asks for repairing under warranty this certificate will have to be shown together with the purchase receipt of the product proving its real place of origin. The warranty exclusively covers the breakdowns of the product determining its wrong working. The guaranteed product will have to carry the same serial number of that indicated on the sales document or it will be invalidated. Warranty means exclusively free repairing or replacement of components recognised as faulty in manufacturing or in material, labour included. Anyway, travelling, stay and/or transport expenses are in charge of the customer. Warranty cannot be enforced in case of damage due to carelessness, use or installation that do not correspond to the supplied directions, tampering with the product and/or the warranty seal, damage due to accidental causes and/or to negligence by the buyer in particular as regards external parts. Besides, it cannot be enforced in case of damage due to connections of the device with tensions different from those indicated or to sudden voltage changes of the mains with which the unit is connected as wall as in case of damage due to inductive/electrostatic discharges or discharges caused by thunderbolt or other phenomena external to the device. The warranty does not include parts that wear out after use, batteries (when supplied), cables, connectors, external parts and plastic bearings, without manufacturing defects. After 24 (twenty-four) months from purchase warranty expires. In this case service will be carried out debiting the replaced parts and labour expenses according to rates in force or to formalities provided by after-sales service. For every contest the place of jurisdiction will be exclusively Bologna.

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